Quality Systems Engineer

## Quality Systems Engineer Apply locations:
Bedford, Massachusetts, United Statestime type:
Full time posted on:
Posted Todayjob requisition :
579885### Job Title Quality Systems Engineer###

Job Description The Quality Systems Engineer is responsible for ensuring an efficient/compliant Quality Management System (QMS), including analysis, development and revision of QMS processes, performance monitoring and continuous improvement, ensuring accuracy and compliance with relevant standards.
** Your role:
*** Takes ownership of Quality processes including-Audits, Document Control, Training, CAPA etc. ensuring that QMS is efficient and meets the regulatory requirements.
* Analyzes QMS metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
* Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.
* Conducts risk assessments activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing robust mitigation strategies to minimize their impact.
* Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
* Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges.
* Participate in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.
* Cultivates effective relationships with internal and external partners, providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.
* Leads cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
* Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.
** You're the right fit if:
*** You have a minimum of 5+ years’ experience in FDA regulated (ISO 13485) medical device quality operations/manufacturing environments, with a focus on QMS compliance, documenting QMS changes, gap assessments, Audits, Document Control, Training, CAPA’s, etc.
* You have experience managing/maintaining training metrics/matrix.
* You have proven experience leading cross-functional teams and the ability to mentor less experienced engineers.
* You have detailed experience/knowledge in CAPA processes, including problem identification, root cause analysis/tools, implementation of solutions to prevent recurrence and drive continuous improvement.
* You’re experienced in Data analysis, understanding QMS metrics/key performance indicators (KPI), preparing detailed reports that highlight trends, deviations, areas for improvement, and presenting findings to senior management.
* You’re able to build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, suppliers etc.
* You have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines. ASQ-CQE, ISO Lead Auditor certifications-desired.
* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
** How we work together:
** We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week.
*** Onsite roles
*** require
** full-time** ***(5 days per week)
*** presence in the company’s facilities. Field roles are most effectively done outside of the…